依折麦布片HPLC含量测定方法学研究

目的建立依折麦布含量测定方法。方法采用高效液相色谱祛，以Agilent SB-C18（5μm，150mm×4．6mm）为色谱柱，以0．05mol／L磷酸二氢钾溶液-乙腈-四氢呋喃（65：25：10）为流动相；检测波长为232nm，柱温为25℃，流速为1．0mL／min。结果含量测定方法学研究表明，该方法专属性好；依折麦布在40．23-402．30μg／mL的浓度范围内与其峰响应值呈良好的线性关系，平均回收率为98．8％（RSD=0.3％）。结论本方法测定结果准确，精密度高，耐用性良好，可以作为依折麦布的含量测定方法。

Study on methodology for determination of ezetimibe in ezetimibe tablets by HPLC

Objective To establish the method for determination of Ezetimibe in Ezetimibe tablets, Methods The assay involved an isocratic elution of ezetimibe in a Agilent SB-C18 column （ 5μm,150mm × 4.6mm ） ,using a mobile phase composition of 0.05mol/L potassium dihydrogen phosphate and acetonitrile and tetrahydrofuran（65 ： 25：10）;The determination wavelength was 232 nm,column temperature was 25℃ and the flow rate was 1.0mL/min, Results After the Study on methodology for determination,It Indicated that the specificity of method was good;andezetimibe had a good linear range of 40.23-402.30μg/mL with a mean recovery of 98.8%（RSD=0.3%）, Conclusion The assay showed an accurate result,high precision and good durability,which can used as a method for determination of Ezetimibe in Ezetimibe Tablets.